Researchers create AERSMine to aid analysis of FDA adverse event data

A team at Cincinnati Children's Hospital Medical Center has created a tool to improve analysis of adverse event data gathered by FDA. The web-based system, AERSMine, is designed to make it easier to dig deep into the data in search of evidence of unexpected harms caused by FDA-approved drugs when given in isolation or alongside other medications.

FDA releases data from its repository of adverse event reports every quarter, but the information is impossible to probe without knowing how to create relational databases. This limits the ability of physicians, researchers and the public to sift through the data in search of trends of relevance to their interests.

Third parties, such as FDAble, have designed systems that make it trivial to search for cases relating to different drugs and the companies that manufacture them, but the team at Cincinnati Children's Division of Biomedical Informatics and the Clinical and Translational Sciences Program thinks there is scope to create more powerful analytical tools.

"One of the capabilities that makes AERSMine different from any other clinical data mining system is its ability to use knowledge frameworks--ontologies--to form the groupings of patients, medications, and outcomes and gain what we believe is an unprecedented power to explore and identify both unexpectedly negative and positive drug effects. Doing this has the potential to uncover new uses for drugs and drug regimen combinations," Bruce Aronow, co-director of the Computational Medicine Center at Cincinnati Children's, said in a statement.

Aronow is also senior study author on a paper published in the journal Nature Biotechnology describing AERSMine. The system supports searches that both include and exclude multiple different drugs, indications and types of adverse event. Users can filter the output of these searches by age group and gender. By providing these search capabilities--and enabling users to visualize the output--the team members think they can improve the utility of data in FDA’s Adverse Event Reporting System.